Phase 1 Clinical Trials

For over Twenty-two years we have conducted investigative studies for both standard and customized in-vitro and clinical studies proving product safety and efficacy on a wide range of products spanning the public consumer industry, healthcare industry, pharmaceutical, food-handling industry, and the cosmetics market. ASTM, AATCC, AOAC, CLSI, and EN standard methods are performed on a regular basis in our labs to support EPA, FDA, TGA and HC registrations and label claims. Our GLP/GCP-compliant Microbiology, Virology, and Clinical Laboratories are audited by various regulatory bodies, individual auditors, and continue to meet the highest quality & standards in the industry. We are very astute in statistical design and evaluate all studies with statistical analysis. We utilized an expansive 15,000 subject database of healthy volunteers to fill and complete our studies.

Our Sponsors receive quality safety data in a reasonable amount of time, with a reasonable fee. From start to finish, Phase 1 Repeat Insult Patch Test, Cumulative Irritation Patch Test, Phototoxicity and Photoallergy Evaluations can all be conducted in as short as a twelve week timeframe. This includes Protocol Development, IRB review, subject recruitment, study management, CRF drafting and printing, document archiving, data management, statistical analysis and ICH final reports.